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Claims for Patent: 7,601,758

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Claims for Patent: 7,601,758

Title:Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares
Abstract:Methods for treating gout flares comprising concomitant administration of colchicine together with one or more macrolide antibiotics, e.g., clarithromycin or erythromycin, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for co-administration of colchicine together with macrolide antibiotics are also provided.
Inventor(s): Davis; Matthew W. (Erwinna, PA)
Assignee: Mutual Pharmaceutical Company, Inc. (Philadelphia, PA)
Application Number:12/368,700
Patent Claims: 1. A method of using colchicine to treat a gout flare in a human patient who is receiving concomitant administration of clarithromycin or erythromycin, said method comprising: determining a first colchicine dosage amount adapted for oral administration to the patient to treat a gout flare in the absence of concomitant administration of clarithromycin or erythromycin, determining a second colchicine dosage amount that is about a two thirds reduction of the first colchicine dosage amount, orally administering the second colchicine dosage amount to the patient who is experiencing a gout flare and is concomitantly receiving administration of clarithromycin or erythromycin, wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount, and not repeating colchicine administration for at least three days.

2. The method of claim 1 wherein the two thirds reduction comprises reducing the number of doses of colchicine administered.

3. The method of claim 1 wherein the two thirds reduction comprises reducing the size of at least one colchicine dose.

4. The method of claim 1 wherein the two thirds reduction comprises reducing both the number of doses of colchicine administered and the size of at least one colchicine dose.

5. The method of claim 1 wherein the patient is an adult.

6. The method of claim 5 wherein the patient is less than 70 years old.

7. The method of claim 1 wherein the patient is receiving concomitant administration of clarithromycin.

8. The method of claim 1 wherein the first colchicine dosage amount is about 1.8 mg per day and the second colchicine dosage amount is about 0.6 mg per day.

9. The method of claim 8 wherein, after administration of the second colchicine dosage amount as a single 0.6 mg dose, ingestion of colchicine is not repeated for at least three days.

10. A method of using colchicine to treat a gout flare in an adult human gout patient so as to reduce the occurrence of colchicine toxicity when said patient is receiving concomitant administration of clarithromycin or erythromycin, said method comprising: administering a reduced colchicine dosage amount to the patient to treat gout flares, wherein the reduced colchicine dosage amount is about 50% to about 75% of a manufacturer's recommended colchicine dosage amount in the absence of concomitant clarithromycin or erythromycin administration, and not repeating colchicine administration for at least three days, wherein concomitant administration of clarithromycin or erythromycin is administration within 1 to 2 days of orally administering the second colchicine dosage amount.

11. The method of claim 10 wherein the reduced colchicine dosage amount is about 0.6 mg per day.
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